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Human Drugs

Accelerated Approval for Gileads Livdelzi

FDA gives accelerated approval to Gileads Livdelzi to treat some cases of primary biliary cholangitis.

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Human Drugs

Verrica Positive Data from Skin Cancer Trial

After reporting preliminary positive results from a Phase 2 clinical trial studying VP-315 in basal cell carcinoma patients, Verrica Pharmaceuticals s...

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Human Drugs

FDA Approves Incytes Niktimvo

FDA approves Incytes Niktimvo for some adult and pediatric host-versus-graft treatments.

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Human Drugs

Workshop on Measuring Gonadal Toxicity

FDA and the American Society of Clinical Oncology announce a 10/1 joint workshop entitled Measuring Toxicity in Reproductive Organs During Oncology Dr...

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Medical Devices

Big Healths SleepioRx Cleared for Sleep Help

FDA clears a Big Health 510(k) for its SleepioRx, a digital therapeutic intended for treating chronic insomnia/insomnia disorder as an adjunct to usua...

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Federal Register

Peripheral/CNS Drugs Panel Renewed

Federal Register notice: FDA renews for two years its Peripheral and Central Nervous System Drugs advisory committee.

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Biologics

Galderma BLA for Nemluvio Approved

FDA approves a Galderma BLA for Nemluvio (nemolizumab), a pre-filled pen for subcutaneous injection for adults with prurigo nodularis.

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Biologics

Objectionable Conditions in Doctors Clinical Trial

FDA warns Lublin, Poland, physician Konrad Rejdak about Bioresearch Monitoring violations in a clinical study for which he was the study director.

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Human Drugs

Nowrez & Ismail Shukri CGMP Violations

FDA warns Jordans Nowrez and Ismail Shukri Company about CGMP violations in the production of OTC drugs.